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Surgical Device For Retracting And/or Sealing An Incision - Patent 7300399

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Surgical Device For Retracting And/or Sealing An Incision - Patent 7300399 Powered By Docstoc
					


United States Patent: 7300399


































 
( 1 of 1 )



	United States Patent 
	7,300,399



 Bonadio
,   et al.

 
November 27, 2007




Surgical device for retracting and/or sealing an incision



Abstract

A wound protector retractor comprises an inner O-ring for insertion
     through a wound opening and a connecting sleeve extending between the
     O-ring and outer mounting means. The outer means are provided by rings
     between which the sleeve is led. The rings are rotated relative to each
     other and the inner ring to form a centralised lumen of reduced cross
     section and to shorten the axial extent of the sleeve. A wound is both
     retracted and protected.


 
Inventors: 
 Bonadio; Frank (Bray, IE), McNally; Shane Joseph (Dublin, IE), McManus; Ronan Bernard (Bray, IE), Young; Derek William (County Dublin, IE), Reid; Alan (Dublin, IE) 
 Assignee:


Atropos Limited
 (County Wicklow, 
IE)





Appl. No.:
                    
10/995,117
  
Filed:
                      
  November 24, 2004

 Related U.S. Patent Documents   
 

Application NumberFiling DatePatent NumberIssue Date
 10133979Apr., 20026846287
 09801826Mar., 2001
 PCT/IE99/00122Dec., 1999
 

 
Foreign Application Priority Data   
 

Dec 01, 1998
[IE]
980997

Feb 15, 1999
[IE]
990111



 



  
Current U.S. Class:
  600/208
  
Current International Class: 
  A61B 1/32&nbsp(20060101)
  
Field of Search: 
  
  











 600/201,206,207,208,235 606/213,215,216 128/846,849,850,888
  

References Cited  [Referenced By]
U.S. Patent Documents
 
 
 
1157202
October 1915
McLeland

1598284
August 1926
Kinney

1810466
June 1931
Deutsch

2219564
October 1940
Reyniers

2305289
December 1942
Coburg

2695608
November 1954
Gibbon

2835253
May 1958
Borgeson

2853075
October 1958
Hoffman

3039468
June 1962
Price

3111943
November 1963
Orndorff

3244169
April 1966
Baxter

3253594
May 1966
Matthews et al.

3313299
April 1967
Spademan

3332417
July 1967
Blanford et al.

3347226
October 1967
Harrower

3347227
October 1967
Harrower

3397692
August 1968
Creager, Jr. et al.

3402710
September 1968
Paleschuck

3447533
June 1969
Spicer

3522800
August 1970
Lesser

3523534
August 1970
Nolan

3570475
March 1971
Weinstein

3656485
April 1972
Robertson

3685786
August 1972
Woodson

3717151
February 1973
Collett

3729006
April 1973
Wilder et al.

3782370
January 1974
McDonald

3797478
March 1974
Walsh et al.

3807393
April 1974
McDonald

3828764
August 1974
Jones

3841332
October 1974
Treacle

3853126
December 1974
Schulte

3853127
December 1974
Spademan

3856021
December 1974
Macintosh

3907389
September 1975
Cox et al.

3915171
October 1975
Shermeta

3965890
June 1976
Gauthier

3996623
December 1976
Kaster

4000739
January 1977
Stevens

4016884
April 1977
Kwan-Gett

4024872
May 1977
Muldoon

4030500
June 1977
Ronnquist

4083370
April 1978
Taylor

4096853
June 1978
Weigand

4130113
December 1978
Graham

4177814
December 1979
Knepshield

4188945
February 1980
Wenander

4217664
August 1980
Faso

4228792
October 1980
Rhys-Davies

4239036
December 1980
Krieger

4240411
December 1980
Hosono

4253201
March 1981
Ross et al.

4306562
December 1981
Osborne

4321915
March 1982
Leighton

4331138
May 1982
Jessen

4338934
July 1982
Spademan

4338937
July 1982
Lehrman

4367728
January 1983
Mutke

4399816
August 1983
Spangler

4411659
October 1983
Jensen et al.

4421296
December 1983
Stephens

4424833
January 1984
Spector

4428364
January 1984
Bartolo

4430081
February 1984
Timmermans

4434791
March 1984
Darnell

4436519
March 1984
O'Neill

4485490
December 1984
Akers et al.

4488877
December 1984
Klein

4543088
September 1985
Bootman

4550713
November 1985
Hyman

4553537
November 1985
Rosenberg

4601710
July 1986
Moll

4610665
September 1986
Matsumoto

4626245
December 1986
Weinstein

4634424
January 1987
O'Boyle

4649904
March 1987
Krauter

4654030
March 1987
Moll et al.

4673393
June 1987
Suzuki et al.

4673394
June 1987
Fenton

4755170
July 1988
Golden

4777943
October 1988
Chvapil

4784646
November 1988
Feingold

4798594
January 1989
Hillstead

4809679
March 1989
Shimonaka

4863438
September 1989
Gauderer

4889107
December 1989
Kaufman

4895565
January 1990
Hillstead

4897081
January 1990
Poirier

4903710
February 1990
Jessamine et al.

4950222
August 1990
Scott et al.

4950223
August 1990
Silvanov

4984564
January 1991
Yuen

4991593
February 1991
LeVahn

4998538
March 1991
Charowsky et al.

5015228
May 1991
Columbus et al.

5019101
May 1991
Purkait

5041095
August 1991
Littrell

5045070
September 1991
Grodecki et al.

D320658
October 1991
Quigley et al.

5071411
December 1991
Hillstead

5074878
December 1991
Bark et al.

5082005
January 1992
Kaldany

5092846
March 1992
Nishijima

5125897
June 1992
Quinn et al.

5141498
August 1992
Christian

5149327
September 1992
Oshiyama

5158553
October 1992
Berry et al.

5159921
November 1992
Hoover

5161773
November 1992
Tower

5167636
December 1992
Clement

5178162
January 1993
Bose

5188595
February 1993
Jacobi

5192301
March 1993
Kamiya et al.

5207656
May 1993
Kranys

5209737
May 1993
Richartt

5211370
May 1993
Powers

5211633
May 1993
Stouder

5213114
May 1993
Bailey, Jr.

5234455
August 1993
Mulhollan

5242409
September 1993
Buelna

5248304
September 1993
Vigdorchik et al.

5263922
November 1993
Sova et al.

5269763
December 1993
Boehmer

D343236
January 1994
Quigley et al.

5279575
January 1994
Sugarbaker

D346022
April 1994
Quigley et al.

5299582
April 1994
Potts

5300036
April 1994
Mueller

5308336
May 1994
Hart et al.

5309896
May 1994
Moll et al.

5316541
May 1994
Fischer

5320611
June 1994
Bonutti

5330437
July 1994
Durman

5330497
July 1994
Freitas

5336192
August 1994
Palestrant

5342385
August 1994
Norelli et al.

5350364
September 1994
Stephens et al.

5364345
November 1994
Lowery et al.

5366478
November 1994
Brinkerhoff et al.

5368545
November 1994
Schaller et al.

5383861
January 1995
Hempel

5385553
January 1995
Hart et al.

5391156
February 1995
Hildwein et al.

5403264
April 1995
Wohlers

5407433
April 1995
Loomas

5429609
July 1995
Yoon

5431676
July 1995
Durbal

5443452
August 1995
Hart et al.

5456284
October 1995
Ryan

5476475
December 1995
Gadberry

5480410
January 1996
Cuschieri et al.

5496280
March 1996
Vandenbrock

5503112
April 1996
Luhman

5514109
May 1996
Mollenauer et al.

5514133
May 1996
Golub et al.

5520632
May 1996
Leveen

5522791
June 1996
Leyva

5522824
June 1996
Ashby

5524644
June 1996
Crook

5526536
June 1996
Cartmill

5545179
August 1996
Williamson, IV

5562632
October 1996
Davila

5562688
October 1996
Riza

5584850
December 1996
Hart et al.

5601579
February 1997
Semertzides

5620415
April 1997
Lucey

5632979
May 1997
Goldberg

5634911
June 1997
Hermann et al.

5634936
June 1997
Linden

5634937
June 1997
Mollenauer et al.

5636645
June 1997
Ou

5640977
June 1997
Leahy et al.

5649550
July 1997
Crook

5653705
August 1997
de la Torre et al.

5657963
August 1997
Hinchliffe

5658272
August 1997
Hasson

5658306
August 1997
Kieturakis

5672168
September 1997
de la Torre et al.

5685854
November 1997
Green

5707703
January 1998
Rothrum et al.

5709664
January 1998
Vandenbrock

5720730
February 1998
Blake, III

5738628
April 1998
Sierocuk et al.

5741234
April 1998
Aboul-Hosn

5741298
April 1998
MacLeod

5749882
May 1998
Hart et al.

5755660
May 1998
Tyagi

5769783
June 1998
Fowler

5782812
July 1998
Hart et al.

5795290
August 1998
Bridges

5803919
September 1998
Hart et al.

5803921
September 1998
Bonadio

5807350
September 1998
Diaz

5810721
September 1998
Mueller et al.

5813409
September 1998
Leahy et al.

5814026
September 1998
Yoon

5817062
October 1998
Flom

5820555
October 1998
Mueller

5832925
November 1998
Rothrum

5853395
December 1998
Crook et al.

5871474
February 1999
Hermann et al.

5882344
March 1999
Stouder

5899208
May 1999
Bonadio

5906577
May 1999
Beane et al.

5916232
June 1999
Hart

5944450
August 1999
Stevens

5947922
September 1999
MacLeod

5951467
September 1999
Picha et al.

5957913
September 1999
de la Torre et al.

5964781
October 1999
Mollenauer et al.

5993485
November 1999
Beckers

5994450
November 1999
Pearce

5997515
December 1999
de la Torre et al.

6024736
February 2000
de la Torre et al.

6025067
February 2000
Fay

6033426
March 2000
Kaji

6033428
March 2000
Sardella

6042573
March 2000
Lucey

6044295
March 2000
Mueller

6048309
April 2000
Flom et al.

6059816
May 2000
Moenning

6077288
June 2000
Shimomura et al.

6110154
August 2000
Shimomura et al.

6123689
September 2000
To

6142935
November 2000
Flom et al.

6142936
November 2000
Beane et al.

6150608
November 2000
Wambeke

6159182
December 2000
Davis

6162172
December 2000
Cosgrove et al.

6162196
December 2000
Hart et al.

6162206
December 2000
Bindokas

6163949
December 2000
Neuenschwander

6164279
December 2000
Tweedle

6171282
January 2001
Ragsdale

6183486
February 2001
Snow et al.

6238373
May 2001
de la Torre et al.

6254533
July 2001
Fadem et al.

6254534
July 2001
Butler et al.

6258065
July 2001
Dennis

6315770
November 2001
de la Torre et al.

6319246
November 2001
de la Torre et al.

6322541
November 2001
West

6346074
February 2002
Roth

6382211
May 2002
Crook

6420475
July 2002
Chen

6440063
August 2002
Beane

6450983
September 2002
Rambo

6454783
September 2002
Piskun

6485435
November 2002
Bakal

6533734
March 2003
Corley, III et al.

6554793
April 2003
Pauker

6578577
June 2003
Bonadio et al.

6582364
June 2003
Butler et al.

6589167
July 2003
Shimonmura

6589211
July 2003
MacLeod

6607504
August 2003
Haarala

6613952
September 2003
Rambo

6623426
September 2003
Bonadio et al.

6706050
March 2004
Giannadakis

6714298
March 2004
Ryer

6723044
April 2004
Pulford

6797765
September 2004
Pearce

6814078
November 2004
Crook

6814700
November 2004
Mueller et al.

6840951
January 2005
de la Torre et al.

6846287
January 2005
Bonadio et al.

6866861
March 2005
Luhman

6884253
April 2005
McFarlane

6902541
June 2005
McNally et al.

6908430
June 2005
Caldwell

6916331
July 2005
Mollenauer et al.

6936037
August 2005
Bubb

6939296
September 2005
Ewers

6958037
October 2005
Ewers

6979324
December 2005
Bybordi

7008377
March 2006
Beane

7052454
May 2006
Taylor

2001/0037053
November 2001
Bonadio et al.

2001/0039430
November 2001
Dubrul et al.

2002/0038077
March 2002
de la Torre et al.

2003/0139756
July 2003
Brustad

2003/0187376
October 2003
Rambo

2003/0192553
October 2003
Rambo

2003/0225392
December 2003
McMichael

2004/0024363
February 2004
Goldberg

2004/0049100
March 2004
Butler

2004/0073090
April 2004
Butler et al.

2004/0092796
May 2004
Butler et al.

2004/0093018
May 2004
Johnson

2004/0106942
June 2004
Taylor

2004/0143158
July 2004
Hart et al.

2004/0215063
October 2004
Bonadio et al.

2005/0020884
January 2005
Heart et al.

2005/0033246
February 2005
Ahlberg

2005/0059865
March 2005
Kahle

2005/0065543
March 2005
Kahle

2005/0090713
April 2005
Gozales

2005/0090717
April 2005
Bonadio et al.

2005/0131349
June 2005
Albrecht

2005/0148823
July 2005
Vaugh et al.

2005/0159647
July 2005
Hart et al.

2005/0192598
September 2005
Johnson

2005/0241647
November 2005
Nguyen

2005/0277946
December 2005
Greenhalgh

2005/0288558
December 2005
Ewers

2005/0288634
December 2005
O'Herron

2006/0041270
February 2006
Lenker

2006/0047284
March 2006
Gresham

2006/0106402
May 2006
McLucas

2006/0149306
July 2006
Hart et al.



 Foreign Patent Documents
 
 
 
37 39 532
Dec., 1988
DE

37 37 121
May., 1989
DE

296 00 939
Jun., 1998
DE

0142262
May., 1985
EP

0537768
Apr., 1993
EP

0950376
Oct., 1999
EP

1118657
Jul., 2001
EP

1456623
Sep., 1966
FR

1151993
May., 1969
GB

1355611
Jun., 1974
GB

1372491
Oct., 1974
GB

1379772
Jan., 1975
GB

1400808
Jul., 1975
GB

1407023
Sep., 1975
GB

1496696
Dec., 1977
GB

2071502
Sep., 1981
GB

2255019
Oct., 1992
GB

2275420
Aug., 1994
GB

10-108868
Apr., 1998
JP

2001-061850
Mar., 2001
JP

2004-195037
Jul., 2004
JP

1342485
Jan., 1997
RU

WO 86/06272
Nov., 1986
WO

WO 92/11880
Jul., 1992
WO

WO 92/21292
Dec., 1992
WO

WO 93/05740
Apr., 1993
WO

WO 95/05207
Feb., 1995
WO

WO 95/07056
Mar., 1995
WO

WO 95/22289
Aug., 1995
WO

WO 95/24864
Sep., 1995
WO

WO 95/27445
Oct., 1995
WO

WO 95/27468
Oct., 1995
WO

WO 96/36283
Nov., 1996
WO

WO 97/32514
Sep., 1997
WO

WO 97/32515
Sep., 1997
WO

WO 98/35614
Sep., 1998
WO

WO 98/48724
Nov., 1998
WO

WO 99/03416
Jan., 1999
WO

WO 99/25268
May., 1999
WO

WO 99/29250
Jun., 1999
WO

WO 00/32116
Jun., 2000
WO

WO 00/32117
Jun., 2000
WO

WO 00/32119
Jun., 2000
WO

WO 00/32120
Jun., 2000
WO

WO 00/35356
Jun., 2000
WO

WO 00/54675
Sep., 2000
WO

WO 00/54676
Sep., 2000
WO

WO 00/54677
Sep., 2000
WO

WO 01/08563
Feb., 2001
WO

WO 01/08581
Feb., 2001
WO

WO 01/26558
Apr., 2001
WO

WO 01/91652
Dec., 2001
WO

WO 02/34108
May., 2002
WO

WO 03/034908
May., 2003
WO

WO 03/061480
Jul., 2003
WO

WO 03/103548
Dec., 2003
WO

WO 2004/026153
Apr., 2004
WO

WO 2004/030547
Apr., 2004
WO

WO 2005/009257
Feb., 2005
WO



   Primary Examiner: Ramana; Anuradha


  Attorney, Agent or Firm: Finnegan, Henderson, Farabow, Garrett & Dunner, LLP



Parent Case Text



CROSS REFERENCE TO RELATED APPLICATIONS


This is a continuation of U.S. application Ser. No. 10/133,979, filed Apr.
     29, 2002 now U.S. Pat. No. 6,846,287, which is a continuation of U.S.
     application Ser. No. 09/801,826, filed Mar. 9, 2001, now abandoned, which
     is a continuation of PCT International Application No. PCT/IE99/00122,
     filed Dec. 1, 1999, all of which are incorporated herein by reference.

Claims  

The invention claimed is:

 1.  A wound protector and retractor device, comprising: a longitudinal axis;  a distal ring;  a proximal ring;  a sleeve extending at least between the distal ring and
the proximal ring and proximal to the proximal ring, the sleeve being axially movable relative to the proximal ring to shorten an axial length of the sleeve located between the distal ring and the proximal ring, wherein a portion of the sleeve is
slidingly received about a portion of the proximal ring during shortening of the axial length of the sleeve;  and a securing arrangement configured to substantially fix the axial length of the sleeve located between the distal ring and the proximal ring
at a desired length.


 2.  The wound protector and retractor device of claim 1, wherein the proximal ring forms a part of the securing arrangement.


 3.  The wound protector and retractor device of claim 1, wherein the sleeve is biased against the proximal ring.


 4.  The wound protector and retractor device of claim 1, wherein the portion of the proximal ring is a radially outer portion.


 5.  The wound protector and retractor device of claim 1, wherein the proximal ring is located within the sleeve.


 6.  The wound protector and retractor device of claim 1, wherein the proximal ring is formed of an elastomeric material.


 7.  The wound protector and retractor device of claim 1, wherein the distal ring is formed of an elastomeric material.


 8.  The wound protector and retractor device of claim 1, wherein a portion of the sleeve located between the distal ring and the proximal ring includes two material layers.


 9.  The wound protector and retractor device of claim 8, wherein the sleeve is wrapped around the distal ring.


 10.  The wound protector and retractor device of claim 8, wherein an end portion of the sleeve is fixedly secured to the proximal ring.


 11.  The wound protector and retractor device of claim 1, further including a seal attached to the wound protector and retractor.


 12.  The wound protector and retractor device of claim 11, wherein the seal includes a forearm seal.


 13.  The wound protector and retractor device of claim 1, wherein the sleeve has a generally uniform cross-sectional size in a plane normal to the longitudinal axis, the cross-sectional size of the sleeve being substantially equal to a size of
at least one of the proximal and distal rings.


 14.  The wound protector and retractor device of claim 13, wherein the cross-sectional size of the sleeve is substantially equal to a size of both of the proximal and distal rings.


 15.  The wound protector and retractor device of claim 1, wherein an inner diameter of the proximal ring is substantially equal to an inner diameter of the distal ring.


 16.  The wound protector and retractor device of claim 1, wherein the proximal ring and distal ring are substantially equal in size.


 17.  The wound protector and retractor device of claim 1, wherein at least one of the proximal and distal rings includes a substantially circular shape.


 18.  The wound protector and retractor device of claim 17, wherein both of the proximal and distal rings include a substantially circular shape.


 19.  The wound protector and retractor device of claim 1, wherein at least one of the proximal and distal rings includes a circular cross-section in a plane containing the longitudinal axis.


 20.  The wound protector and retractor device of claim 19, wherein both of the proximal and distal rings include a circular cross-section in planes containing the longitudinal axis.


 21.  A method for retracting an incision comprising: making an incision in a patient;  providing a wound retractor comprising a central longitudinal axis, a distal ring, a proximal ring, and a sleeve extending at least between the distal ring
and the proximal ring, the sleeve being axially movable relative to the proximal ring and proximal to the proximal ring;  inserting the distal ring through the incision such that the sleeve extends through the incision and the proximal ring is located
outside of the incision;  sliding a portion of the sleeve against a portion of the proximal ring to shorten an axial length of the sleeve located between the distal ring and the proximal ring;  and securing the sleeve to maintain the shortened axial
length of the sleeve located between the distal ring and the proximal ring.


 22.  A method as claimed in clam 21, wherein the proximal ring is located radially within an end portion of the sleeve.


 23.  A method as claimed in claim 21, wherein a portion of the sleeve located between the distal ring and the proximal ring includes two material layers.


 24.  A method as claimed in claim 23, wherein the sleeve is wrapped around the distal ring to form the two material layers.


 25.  A method as claimed in claim 24, wherein the distal ring is formed of an elastomeric material.


 26.  A method as claimed in claim 25, wherein an end portion of the sleeve is fixedly secured to the proximal ring.


 27.  A method as claimed in claim 26, wherein the proximal ring is formed of an elastomeric material.


 28.  A method as claimed in claim 21, further including sealing the wound retractor.


 29.  A method as claimed in claim 28, wherein a seal attached to a proximal end of the wound retractor provides said sealing of the wound retractor.


 30.  A method as claimed in claim 21, wherein the sleeve has a generally uniform cross-sectional size in a plane normal to the longitudinal axis, the cross-sectional size of the sleeve being substantially equal to a size of at least one of the
proximal and distal rings.


 31.  A method as claimed in claim 30, wherein the cross-sectional size of the sleeve is substantially equal to a size of both of the proximal and distal rings.


 32.  A method as claimed in claim 21, wherein an inner diameter of the proximal ring is substantially equal to an inner diameter of the distal ring.


 33.  A method as claimed in claim 21, wherein the proximal ring and distal ring are substantially equal in size.


 34.  A method as claimed in claim 21, wherein at least one of the proximal and distal rings includes a substantially circular shape.


 35.  A method as claimed in claim 34, wherein both of the proximal and distal rings include a substantially circular shape.


 36.  A method as claimed in claim 21, wherein at least one of the proximal and distal rings includes a circular cross-section in a plane containing the longitudinal axis.


 37.  A method as claimed in claim 36, wherein both of the proximal and distal rings include a circular cross-section in planes containing the longitudinal axis.


 38.  A method as claimed in claim 21, wherein the portion of the proximal ring is a radially outer portion.  Description  

BACKGROUND OF THE INVENTION


The present invention relates to a surgical device.  More specifically, the invention relates to devices for retraction of an incision or natural bodily opening during surgery and for protecting the edges of incisions from infection or tumour
seeding during surgery.


Wound Retraction


Adequate anatomical exposure is required in modem surgical procedures to allow procedures to be safely and effectively performed.  Anatomical exposure is achieved by separating the walls of a natural orifice or spreading apart the margins of a
surgical incision.  A difficult surgical procedure can be simplified by adequate retraction whereas a relatively simple procedure can be made more difficult or even dangerous by the lack of adequate retraction.  Exposure is maximised with correct
incision placement and well directed retraction.


Retraction can be achieved in several different ways.  The most common method of surgical wound retraction is by the use of hand held retractors.  These may be made of metal or thermoplastics and allow an operator to apply a retraction force to
the wound edges.  They are disposable or reusable and come in a variety of shapes and sizes to satisfy the requirements of different surgical procedures.


Another type of retractor are Frame mounted retractor devices are also known.  Such devices consist of a rigid circular or horseshoe-shaped frame on which multiple, detachable and movable paddle retractors are attached.  The device may be mounted
to an operating table to provide secure anchorage.  Retraction may be applied in required directions.  Typically such retractors are made of stainless steel to facilitate cleaning and sterilisation for reuse.  Some of the more complex retractors need to
be taken apart before sterilisation and reassembled before use.  These devices always apply retraction at a fewspecific locations on the wound.  This is a disadvantage of such devices as it can lead to regional ischaemia on parts the wound edge.


A wound retractor and protector is disclosed in U.S.  Pat.  No. 5,524,644 (Crook).  This device consists of an open-ended sleeve of polymeric material with a flexible ring at each end.  One ring is inserted into the incision and the sleeve is
manually rolled up around the other ring to apply tension to the polymeric material to achieve retraction.  The device is often difficult to use because of the manual dexterity required, especially when the surgeons hands are wet.  In addition, the
device is incrementally adjustable.  This restricts the efficiency of the device across all abdominal wall thicknesses.


U.S.  Pat.  No. 5,545,179 (Williamson IV) describes a device having an elastomeric sealing element and a tubing conduit.  The device protects the edges of the wound from contamination.  However, the device is specifically for laparoscopic
instruments and is not suitable for hand assisted surgery because the wound opening is not sufficiently retracted.


WO-A-96/36283 (Mollenauer) describes a trocar device for retracting and sealing an incision and providing a sealed access port for surgical instruments.  Whilst this incision and providing a sealed access port for surgical instruments.  Whilst
this device provides both retraction and protection to the wound edge is not suitable for use in hand assisted surgery due to size limitations.  The device retarcts and protects due to the inflation of one or one or more balloons and because these close
the lumen when inflated it is not possible to visulaise the contents of the abdomen through the device.


WO-A-98/48724 discloses a device for use in hand assisted laparoscopic surgery.  The device has a wound retractor/protector component and a component for sealing around the wrist of the surgeon.  The wound protector component consists of an inner
ring and two outer inflatable doughnut-shaped rings mounted vertically on top of another.  The inner and outer rings are linked by an elastomeric sleeve.  Inflation of the two outer rings causes retraction of the elastomeric sleeve.  This device provides
wound retraction and protection but it is not suitable for device has a large vertical profile due to the outer rings.  This restructs reach into the incision and extends the fulcrum of any instruments used in such a way that their effective reach and
breath of lateral movement would be severely restricted.


Wound Protection


The sides of an open wound are susceptible to infection and cross contamination if they are touched by contaminated material such as body parts or fluids as they pass through the opening of a wound.  Serious problems can also result from
cancerous material coming into contact with the wound edge.  It is well known that cancerous cells may become seeded in wound areas, especially at trocar sites.


To avoid such problems great care is taken to protect the edges of an incision using drapes that are impervious to liquids.  An incision liner is disclosed in U.S.  Pat.  No. 3,397,692 (Creager).  This linear comprises a sheet of polymeric
material.  The sheet has a hole cut out in the centre and the edges of the hole are reinforced using a semi-rigid ring.  This ring can be inserted into the incision allowing a surgical procedure to proceed through the ring while the material attached to
the ring protects the edges of the incision from contaminants in the wound site.  These device marketed as "Steridrape" by 3M Corporation and comes in a variety of sizes for different wound sizes.  However such devices do not adequately retract an
incision.


In general known devices are of either complex construction, do not effectively seal a wound and/or are difficult to operate.


There is therefore a need for an improved surgical device that will overcome at least some of these problems.


STATEMENTS OF INVENTION


According to the invention there is provided a surgical device comprising: an inner mounting means for insertion through a wound opening; a first outer mounting means for mounting external of a wound opening; and connecting means extending
between the inner and outer mounting means; the connecting means being movable to shorten the axial extent of the connecting means.


In a particularly preferred embodiment of the invention the outer mounting means is movable relative to the inner mounting means to twist the connecting means to form a lumen of reduced cross section and to shorten the axial extent of the
connecting means.


Most preferably the outer mounting means is rotatable relative to the inner mounting means to twist the connecting means.


In a particularly preferred embodiment of the invention the connecting means is a sleeve of pliable material extending between the inner and outer mounting means.


In one aspect the device includes a second outer mounting means, the connecting means extending between the first outer mounting means, the inner mounting means, and the second outer mounting means.


In this case preferably the first and second outer mounting means are rotatable relative to one another to twist the connecting means and to draw the inner mounting means towards the outer mounting means.  The outer rings also rotate relative to
the inner mounting means.


In a particularly preferred embodiment the inner mounting means is an O-ring; Preferably the connecting means is a sleeve which is led from the first outer mounting means to the O-ring and from the O-ring to the second outer mounting means.


In a preferred embodiment of the invention the device includes locking means for locking the first outer mounting means relative to the second outer mounting means.


In one arrangement one of the outer mounting means is located or locatable within the other outer mounting means.


Preferably the inner diameter of the sleeve is greater than or equal to the axial length of the sleeve.


In a preferred arrangement the inner diameter of the sleeve is greater than the axial length of the sleeve by an amount less than the thickness of an average abdominal wall, which is typically 2 to 6 cm.  This assists in achieving a retraction
force.


Preferably a substantially gas tight seal is formed between the outer mounting means on shortening of the length of the sleeve.  Ideally, the sleeve extending between the first and second outer mounting means defines an inflatable space.


In one embodiment of the invention the device includes a port for connection to an inflation means.


The invention also provides a surgical device comprising: an inner mounting means for insertion through a wound opening; a first outer mounting means; a second outer mounting means; and a sleeve of pliable material extending from the second outer
mounting means to the inner mounting means and from the inner mounting means to the first outer mounting means.


Preferably one or both of the first and second outer mounting means are movable relative to one another to adjust the diameter of the lumen defined by a twist in the sleeve extending therebetween.


Ideally, the first and second outer mounting means are rotatable relative to one another.


In one embodiment of the invention the sleeve is releasably mounted to the second outer mounting means for adjustment of the length of the sleeve.


Preferably the second mounting means comprises a receiver and the sleeve is mounted or mountable to a ring which is releasably mounted to the receiver.


In another embodiment of the invention the inner mounting means is configured to reduce the size thereof for ease of insertion into a wound opening.


Typically in this case the inner mounting means comprises a ring which includes a hinge means for reducing the size of the ring.


A device wherein the connecting means is translated to shorten the axial extent of the connecting means.


A device wherein the connecting means comprises a sleeve which is translated by a drawstring mechanism.


A device wherein the connecting means comprises a plurality of straps attached to the inner mounting means, the straps being pulled upwardly to shorten the axial extend of the connecting means.


Typically the outer mounting means includes a holder for holding a surgical instrument.


The surgical device may form a wound retractor, a wound protector or a wound protector retractor. 

BRIEF DESCRIPTION OF DRAWINGS


The invention will be more clearly understood from the following description thereof given by way of example only with reference to the accompanying drawings, in which:


FIG. 1 is a perspective view of a surgical device according to the invention;


FIG. 2 is a cross sectional view of the device of FIG. 1;


FIG. 3 is a cross sectional view of the device in one position of use;


FIG. 4 is a cross sectional view of the device in another position of use;


FIG. 5 is a top plan view of the device in the position of FIG. 4;


FIGS. 6 and 7 are respectively perspective and cross sectional views illustrating a method of forming the device of FIGS. 1 to 5;


FIG. 8 is a perspective view of another surgical device according to the invention;


FIG. 9 is a cross sectional view of the device of FIG. 8 in one position of use;


FIG. 10 is a cross sectional view of the device of FIG. 8 in another position of use;


FIGS. 11 and 12 are cross sectional views of another surgical device according to the invention in different positions of use;


FIG. 13 is a plan view of the device of FIG. 11;


FIG. 14 is a cross sectional view of a further surgical device according to the invention;


FIGS. 15A and 15B are cross sectional views of the device of FIG. 14, in use;


FIG. 16 is plan view of the device of FIG. 14;


FIG. 17 is a cross section view of another surgical device of invention;


FIG. 18 is a plan view of the device of FIG. 17;


FIG. 19 is a cross sectional view of another surgical device of the invention;


FIG. 20 is a plan view of the device of FIG. 19;


FIG. 21 is a cross sectional view of a further surgical device of the invention;


FIG. 22 is a cross sectional view of a still further surgical device of the invention;


FIG. 23 is plan view of the device of FIG. 22;


FIG. 24 is a perspective view of another surgical device of the invention;


FIG. 25 is a perspective view of the device of FIG. 24 being adjusted;


FIG. 26 is a side, partially cross sectional view of the device of FIGS. 24 and 25;


FIG. 27 is a view similar to FIG. 26 of the device partially disassembled;


FIG. 28 is a view similar to FIG. 26 with the device of FIG. 27 re-assembled;


FIG. 29 is a diagrammatic perspective view of another surgical device of the invention;


FIG. 30 is a perspective view of the device of FIG. 29 in a wound inserting configuration;


FIGS. 31 and 32 are respectively diagrammatic perspective and plan views of an inner ring part of the device of FIGS. 29 and 30;


FIG. 33 is a cross sectional view of two surgical devices ready for assembly;


FIG. 34 is a cross sectional view of the devices of FIG. 33, assembled;


FIG. 35 is a plan view of another surgical device according to the invention;


FIG. 36 is a cross sectional view on the line A-A in FIG. 35 with the device in position in an incision;


FIG. 37 is a plan view of the device of FIGS. 35 and 36 in another position of use; and


FIG. 38 is a cross sectional view on the line B-B of FIG. 37.


DETAILED DESCRIPTION


Referring to the drawings and initially to FIG. 1 to 7 thereof there is illustrated a surgical device, especially for use in laproscopic surgery.  The device 1 in this case is used in surgery involving an incision 2 in a wall 3 of a patients
abdomen.  The wound is, in this case, both protected and retracted by the device 1 of the invention.  Thus, the invention in this case provides a wound protector retractor.


The device 1 comprises an inner mounting means in the form of an O-ring 10 of flexible material such as of elastomeric material for insertion through the wound opening 2, an outer mounting means for mounting external of the wound opening 2 and a
connecting means, in-this-case in the form of a sleeve 11 extending between the inner 10 and outer mounting means.  The outer mounting means is movable, in this case rotatable, relative to the inner O-ring 10 to twist the sleeve 11 to form a centralised
lumen 12 of reduced cross section and to shorten the axial extent of the sleeve 11.  As the sleeve 11 is twisted the inner O-ring 10 is drawn upwardly from the inserted position illustrated in FIG. 3 to the in-use position illustrated in FIG. 4 in which
the wound is sealed and a radial retraction force is applied to the wound.  A surgeon inserts a sealed gloved hand/arm/instrument through the sealed and retracted wound to perform a surgical procedure within the abdomen.


In this preferred case the outer mounting means comprises a first outer mounting means in the form of a first annular ring 20 and a second outer mounting means in the form of a second annular ring 21.  The sleeve 11 is of biocompatible pliable
gas impermeable plastics material and is attached at one end to the ring 20 and at an opposite end to the ring 21.  The sleeve 11 is connected to the ring 20, led over the O-ring 10 and back up for attachment to the ring 21 as best illustrated in FIG. 2.


In use, a surgeon makes an incision in the abdominal cavity and the O-ring 10 is flexed and inserted through the incision as illustrated in FIG. 3.  The outer rings 20, 21 are then rotated relative to one another in the direction of the arrows A
and B in FIG. 3.  This relative rotation twists the sleeve 11 and shortens the sleeve until the device is in the operative position of FIG. 4.  In this position the inner O-ring 10 is engaged against the inside of the interior of the anterior abdominal
wall and the rings 21 and 22 are external of the wound opening with the sleeve 11 shortened in axial extent.  The twisting of the sleeve 11 provides a central lumen 12 of reduced size, which depends on the degree of twist.  A full 180.degree.  relative
twist would result in closing down of the lumen.  The reduced lumen 12 provides access for instruments and/or a surgeons arm while maintaining a wound seal.


Locking means of any suitable type may be provided to lock the rings 20, 21 together.  The locking means may, for example comprise a releasable latching system such as a ratchet and pawl arrangement or the like.


Preferably a gas tight seal is formed between the rings 20, 21 in use.  The sleeve in this case provides an inflatable space 30 between the rings 20, 21 and the inner O-ring 10.  An inflation connection port may be provided in the device to
facilitate inflation.  On inflation, a wound engaging section 11a of the sleeve is pushed radially outwardly to provide a highly efficient wound protector/seal and wound retractor.  The inner sleeve section 11b is inflated to further restrict the lumen
12 and provide highly efficient sealing engagement with a surgeons forearm, a device or an instrument inserted through the lumen.


For efficient sealing engagement it is preferred that the inner diameter (d) of the sleeve 11 is greater than or equal to the axial length (l) of the sleeve 11 as illustrated in FIG. 7.  Preferably the inner diameter of the sleeve is greater than
the axial length of the sleeve by an amount which is less than the thickness of an average abdominal wall.  With this configuration on twisting of the sleeve 11, sealing and retraction forces are applied to the wound opening.


The surgical device 1 may be formed from a cylindrical sleeve 50 of pliable plastic material attached to a pair of rings 20, 21 as illustrated in FIGS. 6 and 7.  A flexible O-ring 10 is fitted over the sleeve 50.  The flexible sleeve 50 is then
turned over on itself so that the O-ring 10 is confined between inner and outer sleeve sections 11a, 11b and the rings 20, 21 are in the configuration illustrated in FIGS. 1 and 2.


The device of the invention applies a force to the wound edges to achieve adequate exposure without causing ischaemic injury to the wound edges.  The device protects wound edges from cross infection or seeding by cancerous or otherwise malignant
cells.  Another advantage is that the device is sufficiently inexpensive that it can be disposed of after a single use thereby obviating the need for cleaning and sterilisation between use.  In addition, the device is simple to place into a desired
position in a wound or natural bodily opening and easy to remove, especially without negating the benefits gained from use of the device as a wound protector.


Referring to FIGS. 8 to 10 there is illustrated another surgical device 60 according to the invention.  The device 60 is similar to the device 1 and like parts are assigned the same reference numerals.  In this case the sleeve 61 is a single wall
sleeve and there is only one outer mounting ring 62.  On rotation of the outer ring 62 relative to the inner ring 10 a twist is formed in the sleeve which is shortened, drawing the inner ring 10 upwardly against the interior of the anterior abdominal
wall as illustrated in FIGS. 9 and 10.


It will be appreciated that the inner O-ring may be fixed, for example, by adhesives to the sleeve of the surgical device.  It will also be appreciated that one or more of the mounting means may be shaped to positively engage with tissue.  For
example, the mounting means may include tissue-engaging projections to lock the mounting means in position.


It will be appreciated that while for efficient retraction and wound protection it is preferred that the connecting means between the outer and inner mounting means is in the form of a sleeve of pliable material, the connecting means may be
discontinuous.  For example the sleeve may be in the form of elongate strips or the like.


Referring to FIGS. 11 to 13 there is illustrated another surgical device 70 according to the invention.  In this case the connecting means comprises a plurality of straps 71 which are drawn upwardly to shorten the axial extent and to form a wound
retractor.  The straps 71 are retained in the shortened configuration illustrated by any suitable locking means such as by wedge elements 72.  In this case an iris diaphragm type device 80 is provided in the wound opening which is inflatable from the
rest configuration illustrated in FIG. 11 to the pressurised inflated configuration illustrated in FIG. 12.


Referring to FIGS. 14 to 16 there is illustrated another device 85 according to the invention in which the connecting means is defined by a plurality of straps 86 which are movable between an inner mounting ring 83 and an outer mounting ring 84
by buckle devices 87 from the initial position illustrated in FIG. 15B to the wound retracting position of FIG. 15A.  The inner ring 83 is first inserted though the incision.  The outer ring 82 is then brought down to skin level by taking up the slack in
the straps 86.  To achieve the retraction effect the straps 86 are pulled taut causing the wound edge to be displaced out from the centrepoint of the wound.  The straps 86 may be adjusted until optimum retraction is achieved.  Tension in the straps 86 is
maintained by the buckles 86 which may hold the strap 86 taut either by friction or using a clasp mechanism.


Referring to FIGS. 17 and 18 another surgical device 90 similar to the device 85 is illustrated.  In this case the inner and outer mounting rings 82, 83 are of oval shape in transverse cross section to smooth the movement of the straps 86.  This
device operates in a similar manner to the device 85.


Referring to FIGS. 19 and 20 there is illustrated another surgical device 93 which has single legged straps 94.  This device operates in a similar manner to devices 85 and device 90.  In this case straps 94 do not loop around the inner ring 83
but are directly attached to it.


Referring to FIG. 21 there is illustrated a further surgical device 95 having straps 96 which are locked in position by a locking mechainism.  The locking mechanism comprises a wedge 97 inserted into a hole through which the strop 96 passes to
hold the strap 96 in position by friction.  A ratchet mechanism may also be used or some other adjustable locking mechanism to hold the strap in position.


The device 98 illustrated in FIGS. 22 and 23 is similar to the device of FIG. 21 except that a different construction of wedge or ratchet 99 is used to lock the straps in position.


Referring to FIGS. 24 to 26 there is illustrated another surgical device according to the invention.  In this case the surgical device is a wound protector retractor 200 of similar construction as that described above with reference to FIGS. 1 to
10.  The device 1 comprises an inner mounting means in the form of a first O-ring 201, a first outer mounting means in the form of a second O-ring 202 mounted in a first receiver 203, and a second mounting means in the form of a third O-ring 205 mounted
in a second receiver 206.  The receivers 203, 206 are in this case interconnectable as illustrated and a fourth O-ring 207 is provided between the receivers 203, 206 on assembly.


A sleeve 210 of flexible pliable plastics material extends from the second outer receiver 206 to the inner O-ring 201 and from the inner O-ring 201 to the first outer receiver 203.  The receivers 203, 206 are de-mountable as illustrated in FIG.
25 to facilitate relative rotation therebetween in the direction of the arrows to vary the degree of twist in the sleeve 210.


Referring to FIGS. 27 and 28 there is illustrated another surgical device 220 which is similar to the device of FIGS. 24 to 26 and like parts are assigned the same reference numerals.  In this case the O-ring 205 is de-mountable from the receiver
206 to facilitate length adjustment of the sleeve 210.  On removal of the O-ring 205 the sleeve 210 is adjusted to a desired length d. In this way a single device 220 may be used for a variety of thickness of abdomens.  The lumen diameter defined by the
twist does not need to be changed to cater for a range of abdomen sizes.  The excess sleeve may be cut off or wound around the O-ring seal 205.


Referring now to FIGS. 29 to 32 there is illustrated part 230 of another surgical device according to the invention which is similar to the devices of FIGS. 24 to 28 and like parts are assigned the same reference numerals.  An inner mounting
means 231 is configured to reduce the size thereof for ease of insertion into a wound opening.  In this case the inner mounting means 231 is in the form of a split ring which is hinged at 232 to facilitate a reduction in the diameter of the ring 231 as
illustrated.  It will of course be appreciated that the hinge may be integrally formed and indeed, there may be a number of such hinges.


Referring to FIGS. 33 and 34 there is illustrated an assembly of two surgical devices 250, 260.  The device 250 is a forearm seal and the device 260 is a wound protector retractor which is assembled to an outer sealing device 250.  The sealing
device 250 provides an outer sealed access port through which a surgeon may insert his forearm or for insertion of an instrument or the like.


Referring to FIGS. 35 to 38 there is illustrated another surgical device 300 according to the invention.  The device 300 is a wound protector retractor similar to those described above.  In this case the wound protector retractor 300 comprises an
inner ring 301 of semi-rigid elastomeric material and an outer ring 302 which is of similar material.  A sleeve 303 of pliable material extends between the rings 301, 302.  Drawstrings 305 are fitted to the sleeve 303, the drawstrings being pulled
outwardly in the direction of the arrows to pull the sleeve 303 upwardly to tighten in the incision and provide a wound protector and retractor.


The invention is not limited to the embodiments hereinbefore described which may be varied in construction and detail.


* * * * *























				
DOCUMENT INFO
Description: The present invention relates to a surgical device. More specifically, the invention relates to devices for retraction of an incision or natural bodily opening during surgery and for protecting the edges of incisions from infection or tumourseeding during surgery.Wound RetractionAdequate anatomical exposure is required in modem surgical procedures to allow procedures to be safely and effectively performed. Anatomical exposure is achieved by separating the walls of a natural orifice or spreading apart the margins of asurgical incision. A difficult surgical procedure can be simplified by adequate retraction whereas a relatively simple procedure can be made more difficult or even dangerous by the lack of adequate retraction. Exposure is maximised with correctincision placement and well directed retraction.Retraction can be achieved in several different ways. The most common method of surgical wound retraction is by the use of hand held retractors. These may be made of metal or thermoplastics and allow an operator to apply a retraction force tothe wound edges. They are disposable or reusable and come in a variety of shapes and sizes to satisfy the requirements of different surgical procedures.Another type of retractor are Frame mounted retractor devices are also known. Such devices consist of a rigid circular or horseshoe-shaped frame on which multiple, detachable and movable paddle retractors are attached. The device may be mountedto an operating table to provide secure anchorage. Retraction may be applied in required directions. Typically such retractors are made of stainless steel to facilitate cleaning and sterilisation for reuse. Some of the more complex retractors need tobe taken apart before sterilisation and reassembled before use. These devices always apply retraction at a fewspecific locations on the wound. This is a disadvantage of such devices as it can lead to regional ischaemia on parts the wound edge.A wound retractor and protector is disclo